Inclusion of Pregnant and Lactating People in Clinical Research: Lessons Learned and Opportunities.

Pregnant and lactating individuals historically have been excluded from research studies because of the ethical concerns surrounding potential harm to the fetus. Several National Institutes of Health and Food and Drug Administration initiatives have attempted to improve inclusion; however, clinical trials continue to exclude pregnant and lactating people. Drug labeling for safety and efficacy in pregnancy has thus been forced to rely on data from animal studies or limited case reports. Recent changes have sought to improve prescriber understanding of risks, benefits, and limitations of safety information on medications; however, confusion persists.